A Phase 3, Multi-center, Randomized, Double-Blind, Placebo-Controlled, Parallel Study to Evaluate the Efficacy and Safety of IN-B00009 Injection in Adults With Obesity or Overweight Without Diabetes Mellitus

This Phase 3 study is designed to evaluate the efficacy and safety of IN-B00009 injection in adults with obesity or overweight without diabetes mellitus

开始日期2025-09-22

申办/合作机构

HK inno.N Corp.

NCT07143227

/ Recruiting临床1期

A Randomized, Double-blind, Placebo-controlled Phase Ib Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Dosing of XW003 Injection in Chinese Adolescents With Obesity

The aim of the study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of XW003 injection in Chinese adolescents with obesity

开始日期2025-08-25

申办/合作机构

杭州先为达生物科技股份有限公司

NCT07073417

/ Recruiting临床2期

A Multicenter, Randomized, Open-label, Treatment Switching Phase II Study to Evaluate the Efficacy and Safety of XW003 Injection and Semaglutide Injection in Chinese Adults With Obesity

The aim of the study is to compare the efficacy and safety of XW003 injection versus semaglutide injection in Chinese adults with obesity

开始日期2025-07-28

申办/合作机构

杭州先为达生物科技股份有限公司

100 项与伊诺格鲁肽相关的临床结果

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100 项与伊诺格鲁肽相关的转化医学

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100 项与伊诺格鲁肽相关的专利（医药）

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项与伊诺格鲁肽相关的文献（医药）

2025-10-01·Lancet Diabetes & Endocrinology

Efficacy and safety of cAMP-biased GLP-1 receptor agonist ecnoglutide versus dulaglutide in patients with type 2 diabetes and elevated glucose concentrations on metformin monotherapy (EECOH-2): a 52-week, multicentre, open-label, non-inferiority, randomised, phase 3 trial

Article

作者: Han, Jie ; Li, Qingju ; Guo, Mengying ; Cheng, Zhifeng ; Pan, Hai ; Zheng, Qing ; Zhou, Yanqin ; Wang, Huihui ; Zhu, Yikun ; Yang, Ming ; Li, Feng ; Guan, Lei ; Wu, Jun ; Ning, Jing ; Zhao, Shuping ; Duan, Binhong ; Shi, Xiaoguang ; Jiang, Feifei ; Mi, Nianrong ; Li, Xiaoying ; He, Yang ; Bing, Shaohui ; Yang, Liu ; Wang, Xin ; Li, Yao ; Wang, Su ; Guo, Wanjun ; Ling, Hongwei ; Bu, Yue ; Xue, Haibo ; Wang, Haifang

BACKGROUND:

Ecnoglutide is a novel biased GLP-1 receptor agonist that preferentially activates the cAMP pathway over β-arrestin recruitment. We aimed to assess both non-inferiority and superiority of ecnoglutide versus dulaglutide, also a GLP-1 receptor agonist, in patients with type 2 diabetes.

METHODS:

We conducted a 52-week, open-label, active-controlled, phase 3 trial at 52 hospitals in China. Adults aged 18-75 years with a BMI of 20-35 kg/m², a diagnosis of type 2 diabetes, and elevated glucose concentrations on metformin monotherapy were included. Participants were randomly assigned (1:1:1) to receive subcutaneous ecnoglutide (0·6 mg or 1·2 mg) or dulaglutide (1·5 mg) once weekly. The primary endpoint was mean change from baseline in HbA_1c at week 32 (non-inferiority for ecnoglutide 0·6 mg and 1·2 mg, with a 0·4% non-inferiority margin; superiority for ecnoglutide 1·2 mg) and was assessed in all randomly assigned participants who received at least one dose of study treatment (full analysis set). Safety was assessed in all randomly assigned participants who received at least one dose of study drug and had at least one safety evaluation after starting treatment. This trial is registered with ClinicalTrials.gov (NCT05680129) and has ended.

FINDINGS:

Between Jan 10 and May 30, 2023, 623 participants were randomly assigned, of whom 621 comprised the full analysis set (mean age 53·9 years [SD 10·1], 347 [56%] males, 274 [44%] females, and mean HbA_1c 8·40% [SD 0·78]; 68·28 mmol/mol [8·56]; 206 in the ecnoglutide 0·6 mg group, 208 in the ecnoglutide 1·2 mg group, and 207 in the dulaglutide 1·5 mg group). At week 32, mean HbA_1c reductions were 1·91% (SE 0·05; -20·86 mmol/mol [0·53]) with ecnoglutide 0·6 mg, 1·89% (0·05; -20·69 mmol/mol [0·54]) with ecnoglutide 1·2 mg, and 1·65% (0·05; -18·02 mmol/mol [0·53]) with dulaglutide. Estimated treatment differences versus dulaglutide were -0·26% (95% CI -0·39 to -0·13; -2·84 mmol/mol [-4·29 to -1·38]) with ecnoglutide 0·6 mg and -0·24% (-0·38 to -0·11; -2·67 mmol/mol [-4·14 to -1·20]; p=0·0002 for superiority) with ecnoglutide 1·2 mg. HbA_1c reductions were sustained to week 52. During the 52 weeks, six (3%) of 206 patients in the ecnoglutide 0·6 mg group, eight (4%) of 208 patients in the ecnoglutide 1·2 mg group, and six (3%) of 207 patients in the dulaglutide group discontinued treatment due to adverse events.

INTERPRETATION:

Once-weekly ecnoglutide 0·6 mg and 1·2 mg were non-inferior to dulaglutide 1·5 mg in reducing HbA_1c in adults with type 2 diabetes and elevated glucose concentrations on metformin monotherapy. Although the 1·2 mg dose showed statistically significantly greater reductions in HbA_1c from baseline to week 32 than dulaglutide 1·5 mg, the difference was not considered clinically relevant. Both doses of ecnoglutide were well tolerated. These results suggest that ecnoglutide might offer a new treatment option for type 2 diabetes.

FUNDING:

Hangzhou Sciwind Biosciences.

2025-01-01·PHARMACOLOGICAL REVIEWS

Emerging pharmacotherapies for obesity: A systematic review

Review

作者: Al Rifai, Jana ; Valenzuela-Vallejo, Laura ; Kokkorakis, Michail ; Rhayem, Caline ; Mantzoros, Christos S ; Mantzoros, Christos S. ; Chakhtoura, Marlene ; Ghezzawi, Malak

The history of antiobesity pharmacotherapies is marked by disappointments, often entangled with societal pressure promoting weight loss and the prevailing conviction that excess body weight signifies a lack of willpower. However, categories of emerging pharmacotherapies generate hope to reduce obesity rates. This systematic review of phase 2 and phase 3 trials in adults with overweight/obesity investigates the effect of novel weight loss pharmacotherapies, compared to placebo/control or US Food and Drug Administration-approved weight loss medication, through searching Medline, Embase, and ClinicalTrials.gov (2012-2024). We identified 53 phase 3 and phase 2 trials, with 36 emerging antiobesity drugs or combinations thereof and 4 withdrawn or terminated trials. Oral semaglutide 50 mg is the only medication that has completed a phase 3 trial. There are 14 ongoing phase 3 trials on glucagon-like peptide-1 (GLP-1) receptor agonists (RAs) (ecnoglutide, orforglipron, and TG103), GLP-1 RA/amylin agonist (CagriSema), GLP-1/glucagon RAs (mazdutide and survodutide), GLP-1/glucose-dependent insulinotropic polypeptide and glucagon RA (retatrutide), dapagliflozin, and the combination sibutramine/topiramate. Completed phase 2 trials on incretin-based therapies showed a mean percent weight loss of 7.4% to 24.2%. Almost half of the drugs undergoing phase 2 trials are incretin analogs. The obesity drug pipeline is expanding rapidly, with the most promising results reported with incretin analogs. Data on mortality and obesity-related complications, such as cardio-renal-metabolic events, are needed. Moreover, long-term follow-up data on the safety and efficacy of weight maintenance with novel obesity pharmacotherapies, along with studies focused on underrepresented populations, cost-effectiveness assessments, and drug availability, are needed to bridge the care gap for patients with obesity. SIGNIFICANCE STATEMENT: Obesity is the epidemic of the 21st century. Except for the newer injectable medications, drugs with suboptimal efficacy have been available in the clinician's armamentarium for weight management. However, emerging alternatives of novel agents and combinations populate the current obesity therapeutic pipeline. This systematic review identifies the state and mechanism of action of emerging pharmacotherapies undergoing or having completed phase 2 and phase 3 clinical trials. The information provided herein furthers the understanding of obesity management, implying direct clinical implications and stimulating research initiatives.

2023-09-01·Molecular metabolism

Discovery of ecnoglutide – A novel, long-acting, cAMP-biased glucagon-like peptide-1 (GLP-1) analog

Article

作者: Wang, Bin ; Adegbite, Eric ; Zou, Haixia ; Feng, Jing ; Qin, Hong ; Zheng, Qing ; Li, Feng ; Pan, Hai ; Zhong, Weidong ; Junaidi, Mohammed K ; Xu, Zheng ; Jones, Catherine L ; Xu, Susan ; Zhu, Rui ; Guo, Wanjun ; Li, Yao ; Li, Yan ; Zhu, Zhiyi ; Fenaux, Martijn ; Hao, Sujuan ; Telusca, Libnir

OBJECTIVE:

Glucagon-like peptide (GLP)-1 is an incretin hormone that acts after food intake to stimulate insulin production, enhance satiety, and promote weight loss. Here we describe the discovery and characterization of ecnoglutide (XW003), a novel GLP-1 analog.

METHODS:

We engineered a series of GLP-1 peptide analogs with an alanine to valine substitution (Ala8Val) and a γGlu-2xAEEA linked C18 diacid fatty acid at various positions. Ecnoglutide was selected and characterized in GLP-1 receptor signaling assays in vitro, as well as in db/db mice and a diet induced obese (DIO) rat model. A Phase 1, double-blind, randomized, placebo-controlled, single (SAD) and multiple ascending dose (MAD) study was conducted to evaluate the safety, tolerability, and pharmacokinetics of subcutaneous ecnoglutide injection in healthy participants. SAD doses ranged from 0.03 to 1.0 mg; MAD doses ranged from 0.2 to 0.6 mg once weekly for 6 weeks (ClinicalTrials.gov Identifier: NCT04389775).

RESULTS:

In vitro, ecnoglutide potently induced cAMP (EC₅₀ = 0.018 nM) but not GLP-1 receptor internalization (EC₅₀ > 10 μM), suggesting a desirable signaling bias. In rodent models, ecnoglutide significantly reduced blood glucose, promoted insulin induction, and led to more pronounced body weight reduction compared to semaglutide. In a Phase 1 trial, ecnoglutide was generally safe and well tolerated as a once-weekly injection for up to 6 weeks. Adverse events included decreased appetite, nausea, and headache. The half-life at steady state ranged from 124 to 138 h, supporting once-weekly dosing.

CONCLUSIONS:

Ecnoglutide showed a favorable potency, pharmacokinetic, and tolerability profile, as well as a simplified manufacturing process. These results support the continued development of ecnoglutide for the treatment of type 2 diabetes and obesity.

156

项与伊诺格鲁肽相关的新闻（医药）

2025-09-24

·BD随笔

近期三个新闻反映出GLP1赛道竞争激烈！

GLP1这个赛道实在是太香了，据不完全统计如下表，在2024年这一块的市场规模达到了380多亿美元，2025年预测可以达到近500亿美元，有预测到2030年可以到达1000亿美元以上。好的赛道都是这样，最开始不拥挤，慢慢Player就越来越多，近期GLP赛道新闻很多，把近期几个串起来看看这个赛道的激烈程度：Pfizer 将收购Metsera；礼来Orforglipron临床结果积极；国内代表性企业之一先为达计划港股IPO。一、辉瑞将收购Metsera 辉瑞GLP1管线上曾经有Lotiglipron，Danuglipron，PF-06954522这几款主要产品，这几款产品命运都不太理想：2023年Lotiglipron由于肝转氨酶升高的问题的研发终止，辉瑞把希望转向Danuglipron，希望通过制剂的开发减少肝毒，可是事与愿违，Danuglipron在试验中发现肝毒性没有得到解决，2025年4月14日辉瑞宣布停止这一款药物的临床开发。彼时辉瑞GLP1管线上只剩下了PF-06954522这根独苗，可是到了8月5日，辉瑞宣布放弃口服GLP-1受体激动剂PF-06954522的开发，这是该公司在过去两年内终止的第三款减肥药物，也是辉瑞的最后一款GLP1药物。辉瑞估计很早看到自己的几个管线不太理想，已经做了二手准备，把眼光投向了Biotech的资产。这也是MNC的常规操作，时间来到2025年9月22号，辉瑞官宣将要收购Metsera，这一收购是对其GLP1管线的有效补充。主要资产包括MET-097i，一种每周和每月注射一次的 GLP-1 受体激动剂 (RA)，处于Ⅱ期开发阶段；MET-233i，一种每月注射一次的胰淀素类似物候选药物，目前正在进行单药治疗和与 MET-097i 联合治疗的Ⅰ期临床研究；其它的两款口服 GLP-1 RA 候选药物，预计将很快启动临床试验。辉瑞将在交易完成时以每股 47.50 美元的价格现金收购 Metsera 所有已发行普通股，价值约为 49 亿美元，额外支付的 CVR 最高可达每股 22.50 美元。此次交易预计将于 2025 年第四季度完成。二、礼来orforglipron临床结果积极 2025年9月16日，礼来公布了3期临床研究ATTAIN-1的详细结果。该研究在肥胖或至少伴有一种体重相关合并症的超重但无糖尿病的成人中，评估了在研药物口服GLP-1受体激动剂orforglipron的安全性和有效性。在第72周时， orforglipron的三个剂量组（6mg、12mg和36mg）均达到主要终点，与安慰剂组相比，实现了显著的体重减轻。此外，所有三个剂量在多项关键次要终点上较安慰剂组均取得了临床意义的结果，包括体重降幅（≥10%、≥15%和≥20%）以及腰围降幅。该研究结果已在2025年欧洲糖尿病研究协会（EASD）年会上公布，并同步发表于《新英格兰医学杂志》。 ATTAIN-1（NCT05869903）是一项为期72周的随机、双盲、安慰剂对照的3期研究，旨在比较orforglipron 6mg、12mg和36mg单药治疗与安慰剂相比，在肥胖或伴有至少一种合并症（高血压、血脂异常、阻塞性睡眠呼吸暂停或心血管疾病）但无糖尿病的超重成人中的有效性和安全性。该研究是首个在该群体中评估了orforglipron在运动及均衡健康饮食（非低热量饮食）基础上作为药物治疗的3期研究。该研究在美国、巴西、中国大陆、印度、日本、韩国、波多黎各、斯洛伐克、西班牙和中国台湾共入组了3127名参与者，并按照3:3:3:4的比例随机分配，接受6mg、12mg 或36mg的orforglipron或安慰剂治疗。该研究的主要目的是证明在BMI≥30.0kg/m²或BMI≥27.0kg/m² 且至少伴有一种体重相关合并症及至少有一次自我报告节食减肥失败史的参与者中，治疗第72周时，orforglipron（6mg、12mg、36mg）组体重较基线的降幅优于安慰剂组。所有接受orforglipron治疗的参与者均以1mg每日一次的剂量起始，每四周增加一次剂量，直至达到最终随机维持剂量：6mg（从1mg起始）、12mg（从1mg起始、增至3mg ，再至6mg ）或36mg（从1mg起始、增至3mg、再至6mg、12mg和24mg ）。仅在出现胃肠道耐受性问题且无法缓解的情况下，才允许减少剂量。据行业朋友消息，Orforglipron原料药已经在中国CDMO进行大吨位生产，这个产品上游的中间体生产商也是摩拳擦掌，准备上产线，上设备大量供货了。三、国内先为达生物冲刺港股 9月19日，杭州先为达生物提交港股18A上市申请，摩根士丹利和中金公司担任联席保荐，公司估值达48.67亿元。先为达生物成立于2017年，致力于满足体重管理领域医疗需求，即将推出核心产品埃诺格鲁肽注射液，为潜在全球首款cAMP偏向型GLP-1受体激动剂，用于治疗超重/肥胖症及2型糖尿病。在全球成GLP-1赛道竞争格局中，先为达生物推出了其自主研发的全球首个偏向型GLP-1受体激动剂埃诺格鲁肽，或将成为减重市场的新变量。在降糖方面，三期临床数据显示，用埃诺格鲁肽治疗24周后糖化血红蛋白（HbA1c）降低2.43%，显著优于司美格鲁肽最大降幅（1.55%），且与替尔泊肽最佳疗效（2.07%）持平。减重方面，今年ADA大会上，北京大学人民医院纪立农教授报告了最新发表在《柳叶刀·糖尿病与内分泌学》杂志上的三期临床结果。研究显示，疗法策略下，扣除安慰剂之后，埃诺格鲁肽在48周时实现了15.1%的平均体重降幅。相比司美格鲁肽（STEP-7试验）在第44周减重约8.5%；替尔泊肽（SURMOUNT-CN试验）最高剂量（15mg）第52周减重约15.1%，埃诺格鲁肽在更短时间内达到显著减重效果，其减重效率和强度非常突出。此外，在三期研究中，92.8%的受试者体重降幅超过5%，这意味着埃诺格鲁肽“不挑病人”，对绝大多数人都有效。特别值得一提的是，先为达正是因为管线的独特优势，和多家海外公司（韩国头部消费医疗公司科玛集团下属Hk Inno.N和英国Verdiva Bio）达成BD交易，潜在交易总额超25亿美元，首付款超一亿美元。基于最近的这些新闻，我们可以看到GLP1赛道竞争激烈，代表性的产品前有诺和诺德的司美格鲁肽，后有礼来的替尔泊肽和快要上市的Orforglipron，目前感觉是双雄争霸。据不完全统计，全球还有超过GLP1相关的100条管线在不同的阶段：60多条在一期临床，40多个在二期，10个左右在三期，个人判断会出现很多好的产品，竞争格局慢慢会形成“三国杀”，再到“多方逐鹿”的格局，这些管线中谁能胜出我们拭目以待。

并购临床3期临床2期IPO临床结果

2025-09-23

·生物谷

晚讯｜8年无癌不是梦，CAR-GPC3 T新疗法助晚期肝癌患者实现5年无病、8年超长生存；腾讯、美团，投出一个减肥药IPO

1. 8年无癌不是梦，CAR-GPC3 T新疗法力挽狂澜，助晚期肝癌患者实现5年无病、8年超长生存 CAR-GPC3 T细胞疗法在晚期肝癌治疗中取得突破，两例患者通过该疗法实现了超过5年的无病生存期和超过8年的总生存期。GPC3作为精准靶向肝癌细胞的“黄金”靶点，在70%~80%的肝细胞癌中高表达，而在正常组织中几乎不表达。国际知名期刊《Cancer Communications》报道了这两例案例，其中一名患者合并腹膜后淋巴结转移，另一名患者有乙肝肝硬化病史。两名患者在接受局部治疗后，均接受了CAR-GPC3 T细胞输注，结果显示肿瘤未复发，且仅需口服抗乙型肝炎病毒药物，无需其他抗癌治疗。这一成果为肝癌患者带来了新的希望，并在CAR-T治疗实体瘤领域取得了重要进展。 2. 腾讯、美团，投出一个减肥药IPO 近日，先为达生物向港交所递交招股书，拟香港主板IPO上市，摩根士丹利、中金公司为其联席保荐人。公司以GLP-1为核心靶点，重点布局肥胖及相关代谢性疾病领域，核心产品埃诺格鲁肽注射液(XW003)是最接近商业化上市的产品。该产品是新型长效GLP-1受体激动剂，能提升降糖、减重疗效，且给药剂量更低。目前，埃诺格鲁肽已完成在中国的超重/肥胖症及2型糖尿病两项适应症的生物制品许可申请，预计2026年实现商业化上市。若顺利获批，有望成全球首款获批的cAMP偏向型GLP-1受体激动剂，但上市后商业化竞争激烈。随着GLP-1产品不断获批，市场竞争加剧，药企需更关注患者多方面诉求。目前，先为达生物正在开发埃诺格鲁肽的口服剂型产品。 3. 细胞培养肉技术体系入选重大示范周子未来申报的“细胞培养肉产业技术体系构建与示范应用场景”成功入选2025年度前沿技术应用场景建设示范名单。该结果经严格程序确定，既认可了企业在合成生物领域的技术积累，也体现了细胞培养肉赛道的发展潜力。周子未来始终以“用科技创新重构未来食品体系，为人类可持续发展提供优质蛋白解决方案”为方向，此次入选的应用场景围绕细胞培养肉全产业链关键环节展开，目前已在核心技术与生产条件上取得阶段性进展。此次入选对企业是推动技术落地与产业协同的重要契机，后续企业将加大研发投入，完善技术体系，加快示范场景建设，并开展产学研合作，推动产业规模化、商业化。 4. 150亿，上海独角兽IPO敲钟了 9月19日，劲方医药科技（上海）股份有限公司登陆港交所，市值约150亿港元。公司由吕强和兰炯两位创新药老兵于2017年在上海创办，累计融资超7轮，此次IPO募资净额约16.7亿港元，创2022年以来港股18A板块之最。公司聚焦肿瘤、自身免疫性疾病等领域，以“全球新”药自主研发为重点，已成为全球最全面RAS靶向药开发企业之一。目前已有八款候选产品，其中五款处于临床开发阶段，包括两款核心产品GFH925和GFH375。文章未提及投资机构、财务顾问及具体融资目的。 5. 广东新会打造全国首个高标准陈皮产业园总投资达8亿元广东江门新会陈皮产业迎来新发展，广东亚太大健康产业有限公司计划投资8亿元，建全国首个陈皮全链条产业园。该产业园占地5.3万平方米，整合种植、加工、销售与文旅体验，形成全产业闭环，已与310户柑农合作，辐射果园4万亩，规划仓储4500吨，预计货值超160亿元。产业园包含六大功能平台，承载标准制定、技术创新和品牌培育使命，将推动中国陈皮产业进入新阶段。新会陈皮被誉为上品，道地性优势使其在中医药等领域地位不可替代。但陈皮行业长期面临痛点，本次发布会授牌仪式是陈皮产业走向现代化交易体系的重要起点。 6. 亚飞生物完成近3亿元B3轮融资，国生资本领投上海亲合力生物医药科技股份有限公司母公司亚飞（上海）生物医药科技有限公司近期完成B3轮融资，投资额近3亿元人民币，由国生资本领投，兰馨亚洲、鸿富资产、执君资本共同参与，未提及财务顾问。本轮融资将为亚飞生物在全球创新药物的临床研究提供动力，加速技术平台和药物研发，满足肿瘤治疗领域迫切的临床需求。亚飞/亲合力生物致力于研发创新型抗癌药物，已开发20个以上创新候选药物，正积极开展合作开发，希望通过特有技术开发国际首创及同类最佳的新药和联用疗法，成为该领域领先的制药企业。本文仅用于学术分享，转载请注明出处。若有侵权，请联系微信：bioonSir 删除或修改！

IPO免疫疗法细胞疗法

2025-09-22

·EndPoints

FDA pushes back decision on Sanofi’s BTK inhibitor; Roche makes a deal with Starpharma

Plus, news about Sciwind Biosciences, Ipsen, Genfit, Ascletis, AusperBio, Ensoma, Jasper Therapeutics, Verrica, Incyte and Johnson & Johnson: 🏛️ FDA delays decision on Sanofi’s tolebrutinib: The company said that some additional data it submitted qualified as a “major amendment,” leading the FDA to push back the decision by three months. Tolebrutinib is a BTK inhibitor being tested for non-relapsing, secondary progressive multiple sclerosis. The new PDUFA date is Dec. 28. — Max Gelman 💊 Roche’s Genentech licenses Starpharma’s drug delivery technology: The company will pay $5.5 million upfront for access to Starpharma’s DEP platform, which Starpharma will use to develop dendrimer-drug conjugates using Roche’s medicines for certain cancer targets. Starpharma could also get development and commercial milestones of up to $564 million, plus tiered royalties on global sales of any products that emerge from the partnership. Roche would have the exclusive worldwide license. The DEP technology is designed to improve solubility, efficacy, pharmacokinetic control and toxicity profiles of drugs, Starpharma said . — Elizabeth Cairns 🇨🇳 Sciwind Biosciences submits IPO pitch: The company, which has an obesity deal with Verdiva Bio, filed for an IPO on the Hong Kong Stock Exchange, joining several other Chinese drug developers looking to go public as China’s biotech sector surges. Sciwind was founded in 2017. It’s expecting approval next year in China for ecnoglutide, its GLP-1 receptor agonist for obesity and type 2 diabetes. Verdiva Bio in January emerged with $411 million and the rights to ecnoglutide and other assets, including an amylin candidate, outside of China and South Korea. — Kyle LaHucik ✔️ Ipsen’s aesthetic product smooths glabellar lines: In a Phase 2 trial, patients treated with IPN10200 had less severe glabellar lines at four weeks compared with placebo. A “substantial majority” of patients had a clinically significant response, defined as a score of “none” or “mild,” at six months compared with placebo and Dysport, a form of botulinum A marketed by Galderma, according to Ipsen. The trial will continue to investigate IPN10200 in forehead or lateral canthal lines, and Ipsen is also planning to move the product into Phase 3 trials. — Elizabeth Cairns 🏥 Genfit stops lead liver failure program: The company attributed the discontinuation following a serious case of peritonitis, or inflammation of the belly lining, in a Phase 2 clinical trial. The French biotech was studying VS-01 in certain patients with acute-on-chronic liver failure. Its independent data monitoring committee said the trial could continue with additional data and monitoring. However, Genfit decided to discontinue the UNVEIL-IT trial as well as a proof-of-concept study assessing the experimental drug in certain people with hepatic encephalopathy or liver failure. Genfit said it would continue preclinical work on the drug in urea cycle disorder. Genfit, which is listed on the Nasdaq and Euronext, saw its shares fall around 10% Monday morning. — Lei Lei Wu 💉 Ascletis’ weight loss shot shows early promise: In a small trial in obesity patients in the US, a single 30 mg dose of Ascletis’s ASC47 plus four 0.5 mg weekly doses of Novo Nordisk’s Wegovy led to a 56.2% greater relative drop in body weight at day 29 versus the same doses of Wegovy alone. However, a single 60 mg dose of ASC47, an adipose-targeted thyroid hormone receptor beta agonist, plus the same doses of Wegovy, only managed a 15.1% bigger reduction. Only around six to nine patients were enrolled in each dose arm. The gastrointestinal tolerability was better with the combo than with Wegovy alone, and there were no discontinuations. — Elizabeth Cairns 💸 AusperBio collects $63M Series B2: With the new funding , the company has raised about $186 million since December . The San Francisco and Hangzhou biotech’s AHB-137 is in pivotal testing for hepatitis B. It said the funds will go toward ongoing clinical trials, an antisense oligonucleotide platform, preclinical work and commercial manufacturing partnerships. Its investors include Qiming Venture Partners and HanKang Capital. Most of its management team comes from Gilead, which markets medicines in hepatitis B. — Kyle LaHucik 💵 Ensoma gets $53M, starts a Phase 1/2 trial: The Boston biotech raised the money from existing investors, including Gilead, 5AM Ventures and Catalio Capital Management. Ensoma also began enrolling patients with X-linked chronic granulomatous disease in a Phase 1/2 trial of EN-374, an in vivo hematopoietic stem cell therapy. The company is led by Sanofi and Genzyme veteran Jim Burns . Back in early 2023, it disclosed an $85 million Series B and an acquisition of Twelve Bio. — Kyle LaHucik 💰 Jasper Therapeutics’ $30M offering: The biotech is developing briquilimab as a treatment for mast cell-driven diseases. It’s selling about 11.7 million shares at $2.43 apiece. — Jaimy Lee 🇯🇵 Verrica to get $10M milestone: The payment is due from Torii Pharmaceutical after Ycanth received approval in Japan to treat molluscum contagiosum, a viral skin infection. Shionogi recently acquired Torii. — Jaimy Lee 🩺 Incyte’s Opzelura is approved for younger kids with eczema: The FDA approved Opzelura, a Janus kinase (JAK) inhibitor that comes in the form of a cream, to treat mild-to-moderate eczema in children 2 years old and older whose disease is not well controlled with certain other therapies. Opzelura was previously approved for those 12 years old and older with eczema and patients with nonsegmental vitiligo. — Lei Lei Wu 💉 FDA approves Johnson & Johnson’s fully injectable Tremfya regimen: The IL-23 blocker previously required an IV induction regimen to begin treatment. J&J said Friday that the regulator approved the subcutaneous induction regimen for Tremfya for adults with moderately to severely active ulcerative colitis, enabling patients to start the therapy with a self-administered injection. — Lei Lei Wu

临床2期临床结果引进/卖出并购上市批准

100 项与伊诺格鲁肽相关的药物交易

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研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
肥胖	申请上市	中国	杭州先为达生物科技股份有限公司	2024-12-17
肥胖	申请上市	中国	美药星（南京）制药有限公司	2024-12-17
2型糖尿病	申请上市	中国	杭州先为达生物科技股份有限公司	2024-11-23
2型糖尿病	申请上市	中国	美药星（南京）制药有限公司	2024-11-23
糖尿病前期	临床3期	-	HK inno.N Corp.	2025-09-22
肾功能不全	临床1期	中国	杭州先为达生物科技股份有限公司	2023-08-21
非酒精性脂肪性肝炎	临床1期	中国	杭州先为达生物科技股份有限公司	2021-06-16
阿尔茨海默症	临床前	中国	杭州先为达生物科技股份有限公司	2023-05-19

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临床结果

适应症

分期

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT05680129 (EECOH-2, Literature) 人工标引	临床3期	2型糖尿病	621	ecnoglutide 0.6 mg	壓膚鏇築衊鬱醖範糧廠(網顧簾製獵憲鏇願蓋觸) = 構製鏇範齋鏇鑰糧蓋齋積積窪窪鑰願蓋壓觸願 (鑰夢糧壓顧製範蓋襯遞 ) 更多	积极	2025-08-22
				ecnoglutide 1.2 mg	壓膚鏇築衊鬱醖範糧廠(網顧簾製獵憲鏇願蓋觸) = 築艱窪膚遞築鬱範鹹簾積積窪窪鑰願蓋壓觸願 (鑰夢糧壓顧製範蓋襯遞 ) 更多
NEWS 人工标引	临床3期	肥胖	-	ecnoglutide	鹹夢構選衊範鑰範膚齋(衊蓋製鹹糧醖憲遞鏇觸) = 觸鬱鬱網憲構遞糧願憲窪觸襯觸窪積餘構構蓋 (繭廠廠選淵範夢觸範蓋 )	积极	2025-06-27
NCT05813795 (SLIMMER, Lancet \| NEWS 1 \| NEWS 2 \| NEWS 3) 人工标引	临床3期	超重 \| 肥胖	664	ecnoglutide 1.2 mg	遞膚遞壓襯築窪齋壓齋(鬱願構鏇餘遞鹹淵壓範) = 壓廠鹹積遞繭廠顧鑰窪構艱繭繭艱觸淵鏇衊膚 (蓋窪衊獵窪積壓艱簾範, 0.8) 更多	积极	2025-06-21
				ecnoglutide 1.8 mg	遞膚遞壓襯築窪齋壓齋(鬱願構鏇餘遞鹹淵壓範) = 艱醖願蓋窪衊夢網夢築構艱繭繭艱觸淵鏇衊膚 (蓋窪衊獵窪積壓艱簾範, 0.9) 更多
CTR20211014 (Literature) 人工标引	临床2期	2型糖尿病	145	Ecnoglutide 0.4 mg	願願膚蓋醖廠鏇壓夢艱(遞襯醖壓鹽夢壓窪選餘) = 觸構獵醖顧鏇艱範鹽鑰顧艱網鹽觸夢餘餘鹽廠 (鬱鏇醖襯築餘鑰憲積範 ) 更多	积极	2024-09-27
				Ecnoglutide 0.8 mg	願願膚蓋醖廠鏇壓夢艱(遞襯醖壓鹽夢壓窪選餘) = 醖鬱鏇鑰網遞繭繭壓鬱顧艱網鹽觸夢餘餘鹽廠 (鬱鏇醖襯築餘鑰憲積範 )
NCT05184322 (ADA2024) 人工标引	临床1期	肥胖	56	Oral Ecnoglutide 7mg (healthy)	衊鏇齋膚蓋夢淵願膚膚(鏇積構蓋夢簾鹽構壓醖) = The most common AEs were mild to moderate gastrointestinal events that occurred during dose escalation. 鏇獵構衊鹽糧艱製獵夢 (網淵襯鹹糧窪構製選繭 ) 更多	积极	2024-06-21
				Oral Ecnoglutide 15mg (healthy)
NCT05680155 (ADA2024) 人工标引	临床3期	2型糖尿病	211	Ecnoglutide 0.6 mg	積鹹淵膚淵襯糧選壓網(鏇糧積觸淵選遞網鹹蓋) = 範遞構憲築淵憲積夢餘淵艱醖遞構襯築醖艱齋 (願範製鑰遞築遞廠鬱鏇 ) 更多	积极	2024-06-21
				Ecnoglutide 1.2 mg	積鹹淵膚淵襯糧選壓網(鏇糧積觸淵選遞網鹹蓋) = 遞觸蓋糧鑰齋遞鹽糧遞淵艱醖遞構襯築醖艱齋 (願範製鑰遞築遞廠鬱鏇 ) 更多
NEWS 人工标引	临床1期	肥胖	56	ecnoglutide	鬱製繭鬱築蓋觸壓蓋遞(壓選觸鬱艱廠網鏇鏇鏇) = 最常见的不良事件包括恶心、头痛、腹泻、呕吐和食欲减退，大多数不良事件的严重程度为轻中度，主要发生在剂量递增期壓醖鑰鬱鹽獵窪蓋糧積 (夢艱積簾齋壓鹹鹽膚窪 )	积极	2024-01-24
				placebo
NCT05680155 (NEWS) 人工标引	临床3期	2型糖尿病	211	Ecnoglutide 0.6 mg	憲願構醖糧觸壓醖糧積(糧構艱鑰淵鏇餘憲鹽鬱) = 選餘網鬱願積糧蓋遞淵窪鹽鑰選顧積選夢襯鹽 (鏇鹹積鹹醖鬱夢襯餘築 ) 更多	积极	2024-01-03
				Ecnoglutide 1.2 mgEcnoglutide 1.2 mg	憲願構醖糧觸壓醖糧積(糧構艱鑰淵鏇餘憲鹽鬱) = 膚鏇衊簾築鏇獵鹹顧壓窪鹽鑰選顧積選夢襯鹽 (鏇鹹積鹹醖鬱夢襯餘築 ) 更多
CTR20213434 (ADA 12023 \| ADA 22023) 人工标引	临床1期	超重 \| 肥胖	60	XW003 1.8 mg	鏇憲繭艱壓積襯鏇遞範(網廠遞廠廠醖網遞範選) = The proportion of participants reporting any AE was similar between cohorts (95.2 to 100% for ecnoglutide vs 90% for placebo). The most frequent AEs were gastrointestinal, including diarrhea and vomiting. No drug-related SAE or drug-related AEs ≥Grade 3 were reported. 膚膚製製壓簾範鬱築遞 (襯顧鹹憲網鏇鏇糧選鹹 ) 更多	积极	2023-06-20
				XW003 2.4 mg
CTR20211014 (ADA 12023 \| ADA 22023) 人工标引	临床2期	2型糖尿病	145	XW003 0.4 mg	鹹膚簾蓋夢壓壓製簾壓(範範積艱膚憲積觸選憲) = 鑰淵蓋製構顧齋鏇製築繭鏇膚網衊膚糧夢壓遞 (獵選衊夢艱憲糧構鹽觸 ) 更多	积极	2023-06-20
				XW003 0.8 mg	鹹膚簾蓋夢壓壓製簾壓(範範積艱膚憲積觸選憲) = 選齋遞積蓋構糧憲窪艱繭鏇膚網衊膚糧夢壓遞 (獵選衊夢艱憲糧構鹽觸 ) 更多